Clinical Research Coordinator

Virginia Heart; Leesburg (VA); In loco; USD 65.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

No nights/weekends

Medical/Dental/Vision

401(k) plan

Short-Term Disability

EAP

Paid vacation

Paid sick leave

Merit-based raises

Career advancement

Referral bonuses

Employee discounts

Appreciation events

Descrizione del lavoro

Virginia Heart in Loudoun/Fairfax is seeking a Clinical Research Coordinator to plan, direct, and analyze cardiac trial activities in an outpatient setting. You will ensure GCP/FDA compliance, coordinate IRB submissions, maintain study records, and train staff.

The role offers competitive wages, strong benefits and opportunities for career growth in a trusted cardiovascular practice. Join a dedicated team focused on safe, effective cardiac care with a collaborative culture and ongoing

Competenze

• Bachelor's degree in Biology or Health Science preferred.
• Minimum three years experience in clinical research coordination, preferably cardiology.
• CCRC or CCRP certification preferred.
• GCP, FDA regulations and IRB requirements knowledge essential.

Mansioni

• Monitor study activities for protocol and regulatory compliance.
• Coordinate start-up activities including IRB submission and site initiation visits.
• Serve as primary contact for sponsors and study teams.
• Maintain accurate study records and regulatory documents.
• Track enrollment and document dropout reasons and contact efforts.
• Ensure informed consent documentation is completed and stored.
• Prepare budgets and manage monetary disbursements.
• Mentor junior staff on protocol procedures and compliance.

Conoscenze

Clinical Research Coordination

GCP/ICH knowledge

FDA regulations

IRB submission

EMR experience

EPIC

Budget management

Time management

Spanish language

Team training

CTMS

Microsoft Excel

Formazione

Biology or Health Science degree

CCRC or CCRP certification preferred

Strumenti

EPIC

CTMS

Microsoft Excel

Descrizione del lavoro

# Clinical Research CoordinatorFair Oaks OfficeFull-Time / Non-ExemptClinical3580 Joseph Siewick Drive Suite 305 Fairfax, VA 22033Apply Now## Job Description#### Location: Loudoun, Fairfax, VA#### Status: Full-Time/Non-ExemptAre you looking for new career opportunities, great wages, excellent benefits, and work-life balance? Follow your heart to Virginia Heart!At Virginia Heart, we are looking for a professional **Clinical Research Coordinator** will plan, direct, evaluate and analyze clinical research trials related to cardiac drug and device trials. Maintaining GCP/ICH guidelines and FDA regulations is always required. When you work with Virginia Heart, you will enjoy a dedicated and experienced staff, competitive wages, excellent benefits and the following rewards and incentives:* No Nights, weekends, or holidays!* Affordable Medical, Dental and Vision plans* 401(k) Retirement Plan* Paid Short-Term Disability* Employee Assistance Program for Mental and Physical well-being* Three Weeks of Paid Vacation upon eligibility* One week of Paid Sick Leave* Annual Merit-Based increases* Career Advancement Opportunities* Employee Referral Bonuses* Employee Discount Programs* Quarterly Employee Appreciation Events to include therapy dogs, raffles, and other fun events.Virginia Heart is Northern Virginia's premier cardiovascular practice, bringing an unparalleled standard of excellence to our patients. We are seeking experienced professionals to join our team in our outpatient cardiology setting. Every employee, at every level, begins their journey at Virginia Heart learning about the history of the organization and its established culture built on trust and integrity. Our employees drive this culture, and we want you to be a part of it. Roles and Responsibilities: * Monitors study activities to ensure compliance with protocols and with relevantfederal, state regulatory and institutional polices. Ensure that all regulatory files are complete, accurate, and up to date.* Coordinate study start-up activities, including IRB submission, site initiation visits, and pre-study visits.* Serves as the primary point of contact for sponsors.* Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms.* Tracks enrollment status of patients and documents dropout information such as dropout causes and patient contact efforts.* Assesses potential patients' eligibility through methods like screening interviews, reviewing medical records, and discussions with physicians and assistant physician providers.* Responsible for education and appropriate documentation of patient informed consent.* Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.* Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.* Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.* Participates in preparation and management of research budgets and monetary disbursements.* Conducting monitoring visits and resolves issues as needed in a timely manner.* Mentor and train junior research staff and new team members on study protocol, procedures and regulatory compliance.* 10% Travel RequiredSkill Requirements and Qualifications:* Biology or Health Science degree, preferred* Fluency in Spanish preferred* At least three years of experience in clinical research coordination, preferably cardiology* Clinical experience preferred* Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred* Strong organizational and analytical skills required* In depth knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements* Proficiency and clinical trial management systems and electronic data capture platforms* Flexibility with working hours to accommodate study needs* Detailed oriented, excellent written and verbal communication skills* Excellent time management skills, team player with the ability to work independently* EMR experience, (EPIC a plus) and Microsoft Excel, Word and Outlook